ISO Lead Auditor

Job highlights

• Competence in ISO 9001:2015 and ISO 13485:2016 audits with medical device industry knowledge
• Conduct and plan management system certification audits, evaluate QMS effectiveness, prepare audit reports, and ensure certification body compliance

Role & responsibilities:

1. Management System Certification Audits

• Conduct ISO 9001:2015 Quality Management System audits and/or ISO 13485:2016
  Medical Device Quality Management System audits according to demonstrated
  competence and formal authorization.

• Perform Stage 1, Stage 2, surveillance, recertification and special audits, as
  applicable.

• Evaluate the implementation, conformity and effectiveness of clients' management
  systems.

• Review quality manuals, policies, procedures, records and relevant regulatory
  documentation.

• Identify nonconformities based on objective evidence.

• Prepare detailed audit reports, findings and conclusions.
  2. Audit Planning and Execution

• Prepare and execute audit plans, checklists and audit programmes as assigned.

• Coordinate with audit team members and technical experts.

• Ensure timely submission of audit reports and associated records.
  3. ISO 9001:2015 Audit Competence

• Demonstrate knowledge of ISO 9001:2015 requirements and quality management
  principles.

• Evaluate organizational processes, customer requirements, performance monitoring,
  risk-based thinking and continual improvement.

• Possess relevant knowledge of industry-specific technical areas.

• Demonstrate competence in third-party QMS certification auditing.
  4. ISO 13485:2016 Audit Competence

  • Demonstrate knowledge of ISO 13485:2016 requirements applicable to medical
    device organizations.
  • Evaluate medical device QMS documentation, design and development controls,
    production controls, traceability and applicable regulatory requirements.
  • Assess risk management interfaces, validation activities and supplier controls.
  • Demonstrate relevant technical knowledge of medical device products, manufacturing
    processes and regulatory requirements.
  • Possess medical device industry or certification audit experience appropriate to the
    proposed technical areas.
    5. Certification Body Compliance
  • Follow applicable requirements of ISO/IEC 17021-1:2015 and Assuretica's
    documented certification procedures.
  • Maintain impartiality, objectivity, independence and confidentiality.
  • Declare potential conflicts of interest before accepting audit assignments.
  • Participate in competence evaluation, witnessed audits, training and ongoing
    performance monitoring.
  • Maintain current records of qualifications, training and audit experience.
  • Cooperate with applicable accreditation assessment activities.